kinderBAND CL-4000

GUDID 00863457000302

The kinderBAND™ cranial remolding orthosis is a custom made orthotic device available by prescription only. It is used to treat infants between 3 and 18 months of age for asymmetrical head shapes such as positional plagiocephaly, brachycephaly and scaphocephaly.

BIOSCULPTOR CORPORATION

Cranial orthosis
Primary Device ID00863457000302
NIH Device Record Key183677cf-dc86-43f4-9f0c-01cad1174027
Commercial Distribution StatusIn Commercial Distribution
Brand NamekinderBAND
Version Model NumberCL-4000
Catalog NumberCL-4000
Company DUNS926813379
Company NameBIOSCULPTOR CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net
Phone877-246-2884
Emailinfo@kinderband.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100863457000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVAOrthosis, Cranial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-03

Devices Manufactured by BIOSCULPTOR CORPORATION

00810050250771 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are
00810050250788 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are
00810050250795 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are
00810050250801 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are
00810050250818 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are
00810050250825 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are
00810050250832 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are
00810050250849 - Maramed Orthopedic Systems2023-12-07 The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are

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